Intravascular Cryotherapeutic Device for Renal Nerve Modulation
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Solution Overview
Problem
Current pharmacologic strategies for managing excessive renal sympathetic activity, which contribute to hypertension and renal disease, have limited efficacy, compliance issues, and significant side effects, necessitating alternative treatment approaches.
Innovation Solution
Development of cryotherapeutic devices and systems for intravascular neuromodulation that cryogenically modulate renal nerves to reduce sympathetic activity, using a cryotherapeutic system with a console and a cryotherapeutic device featuring a shaft with a cooling assembly that can be deployed in a renal artery to effectively cool renal nerves, thereby inhibiting neural communication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If pharmacologic strategies are used to manage excessive renal sympathetic activity, then treatment can be administered orally, but efficacy is limited and side effects are significant
Solution Approach 1:
The patent replaces pharmacologic (chemical) mechanisms with a mechanical/catheter-based delivery system that directly introduces cryogenic cooling to renal nerves. The device uses a catheter with cooling elements positioned within the renal artery to deliver cold temperatures directly to target nerves, substituting the need for oral medications with a minimally invasive procedural approach that achieves more reliable sympathetic denervation.
Solution Approach 2:
The invention applies local quality by delivering cooling therapy specifically to the renal nerves within the renal artery, rather than systemically affecting the entire body through oral medications. The catheter-based system allows precise localization of the cryotherapeutic effect to the sympathetic nerve fibers in the renal vasculature, improving efficacy while reducing unwanted side effects.
2Ease of operation
If pharmacologic strategies are used to manage excessive renal sympathetic activity, then treatment can be administered orally, but compliance issues arise
Solution Approach 1:
The patent substitutes the chronic oral medication regimen with a one-time or limited-number-of-procedures catheter-based therapy. By delivering renal sympathetic denervation directly during a minimally invasive procedure, the system eliminates the need for ongoing patient compliance with daily medications, addressing the compliance issue head-on.
Solution Approach 2:
The invention performs the sympathetic denervation action during a procedural intervention rather than requiring continuous patient action through oral medications. The preliminary catheter-based treatment achieves the neural modulation effect before the patient would need to rely on ongoing medication compliance, effectively addressing the compliance challenge.
3Ease of operation
If pharmacologic strategies are used to manage excessive renal sympathetic activity, then treatment can be administered orally, but side effects are significant
Solution Approach 1:
The patent applies local quality by delivering cooling therapy specifically to the renal nerves within the renal artery, rather than systemically affecting the entire body through oral medications. The catheter-based system allows precise localization of the cryotherapeutic effect to the sympathetic nerve fibers in the renal vasculature, improving efficacy while reducing unwanted side effects.
Solution Approach 2:
The invention replaces systemic pharmacologic action with a localized mechanical cooling delivery system. By using a catheter with cooling elements positioned directly within the renal artery, the system achieves neural modulation without the widespread side effects associated with oral medications that affect multiple body systems.
4Reliability
If cryotherapeutic devices are deployed in renal arteries to cool renal nerves, then neural communication is inhibited, but the procedure is minimally invasive rather than traditional
Solution Approach 1:
The patent replaces complex surgical sympathectomy procedures with a minimally invasive catheter-based system. Instead of requiring open surgery to access and destroy renal nerves, the invention uses a catheter that can be advanced through the vascular system to deliver cooling directly to the nerves, significantly reducing procedural complexity while maintaining therapeutic effectiveness.
Solution Approach 2:
The invention uses the renal artery itself as an intermediary pathway to deliver the cryotherapeutic device to the target nerves. Rather than directly accessing nerves through complex surgical dissection, the catheter is advanced through the vascular lumen, using the artery as a natural conduit to reach the sympathetic nerve fibers for cooling.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The cryotherapeutic approach provides a minimally invasive method to reduce renal sympathetic activity, potentially treating hypertension, heart failure, and renal disease by inhibiting neural communication, offering a more effective and less painful alternative to traditional pharmacologic treatments.
Implementation Method 1
cryotherapeutic devices and systems for intravascular neuromodulation that cryogenically modulate renal nerves to reduce sympathetic activity
Implementation Method 2
a cooling assembly that can be deployed in a renal artery to effectively cool renal nerves
Data Source
AI summary
Neuromodulation cryotherapeutic devices and associated systems and methods are disclosed herein. A cryotherapeutic device configured in accordance with a particular embodiment of the present technology can include an elongated shaft having distal portion and a supply lumen along at least a portion of the shaft. The shaft can be configured to locate the distal portion intravascularly at a treatment site proximate a renal artery or renal ostium. The supply lumen can be configured to receive a liquid refrigerant. The cryotherapeutic device can further include a cooling assembly at the distal portion of the shaft. The cooling assembly can include an applicator in fluid communication with the supply lumen and configured to deliver cryotherapeutic cooling to nerves proximate the target site when the cooling assembly is in a deployed state.